Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.

Sponsor

Fundación Pública Andaluza Progreso y Salud (Other)

Overall Status

Terminated

CT.gov ID

NCT01875263

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

0.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical and microbiological criteria.

Condition or Disease	Intervention/Treatment	Phase
Staphylococcus	Drug: Cloxacilin Drug: Cloxacillin Drug: Levofloxacin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of a Short-term Sequential Therapy Versus Intravenous Standard Treatment for Patients With Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days.	Drug: Cloxacilin 2g/4 hours i.v., 5 days Drug: Levofloxacin 500 mg v.o./24h, 9 days
Active Comparator: Control Cloxacillin 2g / 4 hrs iv 14 days	Drug: Cloxacillin 2g/4h 14 days Standard therapy

Arm

Intervention/Treatment

Experimental: Experimental

Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days.

Drug: Cloxacilin

2g/4 hours i.v., 5 days

Drug: Levofloxacin

500 mg v.o./24h, 9 days

Active Comparator: Control

Cloxacillin 2g / 4 hrs iv 14 days

Drug: Cloxacillin

2g/4h 14 days Standard therapy

Outcome Measures

Primary Outcome Measures

Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%. [18 months]

Secondary Outcome Measures

Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus. [18 months]
Reduce the transesophagic echocardiography [18 months]
Increase efficiency in the management of patients with bacteremia due to MS S. aureus, reducing the number of echocardiographic evidence

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients ≥ 18 years with a minimum weight of 40 kg.
Microbiological Isolation of S. aureus susceptible to meticillin.
Start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations.
Women of childbearing potential, negative pregnancy test negative serum or urine or statement is not pregnant.
Prescription prior treatment must be independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice.

Exclusion Criteria:

Polymicrobial bacteremia.
Neutropenic patients.
Patients addicted to intravenous drugs.
Patients with malignancies with expected survival less than 6 months.
Severe allergy to beta-lactams or fluoroquinolones.
Creatinine clearance <20ml/min.
Need for hemodialysis, peritoneal dialysis or plasmapheresis.
Clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of IE, embolic events, suppurative thrombophlebitis.
Predictors of bacteremia complicated:
Positive blood cultures for 48-96 hours of starting treatment antistaphylococcal
Clinical Instability
Signs of sepsis or persistent fever at day 4 of treatment
Existence of valvular or vascular prosthetic joints, vascular catheter not removed within three days
Heart disease predisposing to endocarditis.
Patients presenting diagnosis concomitant infection by another organism.
Pregnant or breast-feeding.
Patients with epilepsy.
Patients with a history of tendon disorders related to fluoroquinolone administration.
Not have signed informed consent.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital de Jerez de la Frontera	Jerez de la Frontera	Cádiz	Spain
2	Hospital Costa del Sol	Marbella	Málaga	Spain
3	Hospital Universitario Reina Sofía	Córdoba		Spain
4	Hospital Universitario Virgen de las Nieves	Granada		Spain
5	Complejo Hospitalario de Huelva	Huelva		Spain
6	Hospital Can Misses	Ibiza		Spain
7	Hospital Comarcal Carlos Haya	Málaga		Spain
8	Hospital de Antequera	Málaga		Spain
9	Hospital Universitario Virgen de la Victoria	Málaga		Spain
10	Hospital Universitario Virgen de Valme	Sevilla		Spain
11	Hospital Universitario Virgen del Rocío	Sevilla		Spain